Eardrum perforation patch and eardrum undersurface scraper

ABSTRACT

An eardrum perforation patch and an eardrum undersurface scraper for application of the patch. The eardrum perforation patch comprises double plates connected together with a coupler and these elements are made of artificial material. The plates comprise a supporting piece and a closure piece. After being inserted into the tympanic perforation the closure piece pinches the perforation margin and it stays steadily in place until it changes to a new part of the tympanic membrane. The eardrum undersurface scraper comprises a shaft, a neck and a head with a blade edge. The neck is curved at an angle of more than 90 degrees, twisted and rotated, so that the blade edge gains access to target points behind the tympanic membrane and scrapes and entirely rakes out the mucosal barrier on the undersurface grafting bed of the tympanic membrane through the tympanic perforation. The combination of the eardrum perforation patch and the eardrum undersurface scraper is useful in repairing the tympanic perforation.

FIELD OF THE INVENTION

The invention relates to a patch for repair of an eardrum perforation,and an oto-surgical tool to provide a transplantation bed in theundersurface of the eardrum for grafting the patch.

DESCRIPTION OF THE BACKGROUND ART

One method for treatment of a tympanic perforation uses a graft patchwhich is placed on the undersurface of the tympanic membrane afterintroducing the patch through the perforation. This grafting methodbelongs to the group of undersurface techniques. Because this surgicalmethod is always performed through the external ear canal and thetympanic perforation, it minimizes surgical invasion and therefore ispreferable. The grafting material of the patch in conventional methodsis usually made of living human tissue, for example, temporalis fasciaor subcutaneous connective tissue which is taken from the patientthrough an incision in his or her scalp during the operation.

In preparation of the tympanic membrane remnant for grafting, trimmingof the perforation margin is performed by using a pick and a tiny cupforceps, and otherwise scoring is performed on the undersurface of theremnant membrane by inserting the head of a very tiny sharp-spoon, thetip of an angled pick or the tip of a curved injection needle throughthe perforation.

In order to fix the graft close to the undersurface of the tympanicmembrane remnant, some gelatin sponge is packed in the tympanic cavityto support the graft temporally, or some fibrin glue is applied so thatthe graft adheres to the tympanic membrane remnant.

Generally speaking, a grafting technique should minimize its harm to thepatient's body. In some prior methods, grafting material is obtained bymaking a new incision in some other area of the patient's body. Thisincision gives the patient additional pain and injury.

On the other hand, if artificial material, for example, lyophyrized duraas collagen fiber membrane is used, it increases the possibility ofpostoperative detachment because of its lack of vascularity. Thisusually results, in the whole graft falling off, or slit formation andsubsequent graft failure. Therefore, it is hard to expect success ofperforation closure with artificial grafting material.

For good blood circulation and to promote growth of fibroblast andcapillary vessels in the graft, the contact of the graft with thevascular bed should be direct, tight and stable.

If absorbable gelatin sponge is packed in the tympanic cavity in orderto support the graft temporally, the gelatin sponge irritates themucosal lining of the tympanic cavity and induces hypersecretion andinfection and otorrhea are apt to occur. The packing also interruptsimmediate improvement of hearing after the operation as well.

If fibrin glue is used as an adhesive medium, supporting means islargely free of these problems. But the glue itself is apt to bedissolved by secretion in the tympanic cavity in the healing process.This brings about a loss of contact of the graft with the tympanicmembrane remnant and often results in falling off of the graft.

There should also be a good blood supply to keep the reconstructedcomponent viable. This requires that the mucosa at the back of thefibrous lamina propria around the perforation be entirely removed toprovide a vascular bed for the undersurface grafting.

But trimming of the margin around the tympanic perforation cannotprovide any suitable vascular bed, and, to make matters worse, it getsthe perforation larger and increase the time of postoperative healing.

Scoring undersurface around the perforation removes the mucosal layeronly partially in lines. Therefore, the graft cannot directly contactthe vascular bed because of mucosal barrier. The fibroblast andcapillary vessels can hardly enter into the collagen fiber network ofthe graft as a result.

Those are some of the inherent problems in the prior undersurfacetechniques and they lead to graft failure in eardrum perforation repair.

SUMMARY OF THE INVENTION

The purpose of the present invention is to solve these serious problemsin the conventional techniques for eardrum perforation repair asmentioned above, and to provide an eardrum perforation patch and aneardrum undersurface scraper to conveniently close the tympanicperforation using artificial material instead of living human tissuewith a high success rate.

That is, an eardrum perforation patch of the present invention ischaracterized in that it comprises double plates connected together witha coupler and these elements are made of artificial material. Afterbeing inserted into the tympanic perforation, the plates pinch theperforation margin and will therefore stay in place steadily until atleast the inner plate changes to a new part of the tympanic membrane. Aneardrum undersurface scraper of the present invention is characterizedin that it has a neck which is curved, twisted and/or rotated, so thatits blade edge gains access to target points behind the tympanicmembrane. The blade edge scrapes and entirely rakes out the mucosallayer on the undersurface around the perforation margin only through thetympanic perforation in order to prepare a grafting bed for the patchwith sufficient vascularity for promoting new vasculization of theeardrum perforation patch.

The present perforation patch has a benefit of not requiring livinghuman tissue as grafting material. It therefore avoids unnecessaryincision and harmful pain to the patient.

The eardrum perforation patch of the present invention also needsneither packing in the tympanic cavity for support nor adhesive medium.The contact of the graft with the vascular bed is stable, and thehearing loss due to the perforation decreases immediately after theoperation.

The eardrum undersurface scraper has another benefit in that it entirelyremoves mucosal layer on the undersurface of the tympanic membrane andexposes a vascular bed as a grafting bed only through the tympanicperforation. The tympanic membrane remnant need neither be elevated norbe incised for visualization of the undersurface of the eardrum at all.All existing useful skin layer and lamina propria are preserved.

Furthermore, the present invention either eliminates or greatlydiminishes all of the above problems of the conventional undersurfacetympanoplasty techniques through the tympanic perforation. Thisinvention is therefore simple, safe, reasonable and yields a high degreeof success.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus are not limitativeof the present invention, and wherein:

FIG. 1 is a perspective view of a first embodiment of an eardrumperforation patch of the present invention;

FIG. 2 is a front view of the first embodiment of an eardrum perforationpatch of the present invention;

FIG. 3 is a side view of the first embodiment of an eardrum perforationpatch of the present invention;

FIG. 4 is a rear view of the first embodiment of an eardrum perforationpatch of the present invention;

FIG. 5 is a side view of the first embodiment of an eardrum perforationpatch of the present invention being held at the perforation of thetympanic membrane shown in cross section;

FIG. 6 is a schematic illustration of the first embodiment of an eardrumperforation patch being inserted with a forceps into the tympanicperforation;

FIG. 7 is a front view of a second embodiment of an eardrum perforationpatch of the present invention;

FIG. 8 is a side view of the second embodiment of an eardrum perforationpatch of the present invention;

FIG. 9 is a perspective view of a first embodiment of an eardrumundersurface scraper of the present invention;

FIG. 10 is a partial enlarged view showing a detail of the head and neckof the first embodiment of an eardrum undersurface scraper of thepresent invention;

FIG. 11 is a schematic illustration of the first embodiment of aneardrum undersurface scraper of the present invention being applied tothe tympanic membrane shown in cross section;

FIG. 12 is a perspective view of a second embodiment of an eardrumundersurface scraper of the present invention;

FIG. 13 is a partial enlarged view showing a detail of the head and neckof the second embodiment of an eardrum undersurface scraper of thepresent invention;

FIG. 14 is a schematic illustration of the second embodiment of aneardrum undersurface scraper of the present invention being applied tothe tympanic membrane shown in cross section;

FIG. 15 is a partial enlarged view showing a detail of the head and neckof a third embodiment of an eardrum undersurface scraper of the presentinvention;

FIG. 16 is a schematic illustration of the third embodiment of aneardrum undersurface scraper of the present invention being applied tothe tympanic membrane;

FIG. 17 is a partial enlarged view of a detail of the head and neck of afourth embodiment of an eardrum undersurface scraper of the presentinvention;

FIG. 18 is a schematic illustration of the head and neck of the fourthembodiment of an eardrum undersurface scraper of the present inventionbeing applied to the tympanic membrane shown in cross section;

FIG. 19 is a partial enlarged view of a detail of the head and neck of afifth embodiment of an eardrum undersurface scraper of the presentinvention;

FIG. 20 is a partial enlarged view of a detail of the head and neck of asixth embodiment of an eardrum undersurface scraper of the presentinvention;

FIG. 21 is a partial enlarged view of a detail of the head and neck of aseventh embodiment of an eardrum undersurface scraper of the presentinvention; and

FIG. 22 is a side view of yet another embodiment of an eardrumperforation patch of the present invention being held at the perforationof the tympanic membrane shown in cross section.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

First, the details of the present invention are described about eardrumperforation patches, and second, about eardrum undersurface scrapersseparately.

The eardrum perforation patch comprises a closure piece 1, at least onecoupler 2 and a supporting piece 3 as shown in FIGS. 1-4. The closurepiece 1 and the supporting piece 3 are shaped as a disc and sutured witha traction thread as the coupler 2. The closure piece 1 and supportingpiece 3 are parallel with a narrow gap therebetween. The closure piece 1and the supporting piece 3 have the same diameter with 1 to 2 mm.overlap around the entire circumference of the tympanic perforation tobe closed.

The closure piece 1 is made of an absorbable artificial material withbiological affinity for living tissue such as collagen fiber membrane,for example, lyophyrized human dura. The supporting piece 3 is made ofthe same material as the closure piece 1 or less absorbable material,for example, chitinous fiber membrane. The traction thread as thecoupler 2 is made of surgical suture thread which is absorbable byliving tissue.

When the tympanic perforation is small, the supporting piece 3 can beomitted. Because a large flat bow is made in the knot at an end of thetraction thread as a coupler 2, it plays the role of the supportingpiece 3 instead of a disc shaped plate as shown in FIG. 22.

The eardrum perforation patch is packed and sealed in a bag, andsterilized with ethylene dioxide gas, and is reserved for later surgery.

Turning to FIG. 5, the closure piece 1 is made of absorbable materialwith affinity for living tissue such that it becomes tissuemultiplication ground, and granulation tissue creeps into the voids orgaps in its fiber network from the vascular bed of the lamina propria 8,and grows dissolving and absorbing the network. Capillary vessels willmigrate into the closure piece 1 such that it changes into new laminapropria continuing the original one followed by propagation of skinlayer outside it and mucosal layer inside it.

The supporting piece 3 keeps the closure piece 3 moist and protects itfrom drying and permits the growth of the granulation tissue. Thesupporting piece 3 pulls the closure piece 1 outward and supports theclosure piece 1 through the coupler 2. The pair of the closure piece 1and supporting piece 3 pinches the perforation margin tightly from bothinside and outside.

The fastening mechanism is useful for holding the grafted closure piece1 steady in place and for keeping it in tight contact with the vascularbed around the perforation margin for a long time preventing the closurepiece 1 from falling off until the closure piece 1 is organized andchanges to a new part of the normal tympanic membrane.

Within a few months the coupler 2 is dissolved and absorbed by creepinggranulation tissue, and the supporting piece 3 migrates externally ashealing occurs and naturally falls off and forms ear cerumen. Thesupporting piece 3 can be removed from or can simply fall from theexternal ear canal 6.

An eardrum perforation patch being inserted with forceps 9 into thetympanic perforation is shown in FIG. 6. When applying the patch, thepatch is taken out from the sterilized bag and is custom-trimmed forgrafting. As shown in FIG. 6, only the closure piece 1 is folded onitself, and is nipped by a pair of forceps 9, and is inserted into thetympanic cavity through the tympanic perforation 5 in the direction ofarrow A, and then is released from the forceps 9. After releasing, theclosure piece 1 unfolds and returns to its original shape as a discbehind the tympanic membrane because of its elasticity. The supportingpiece 3 covers the tympanic membrane. Then the final position of thepatch is adjusted.

As shown in FIG. 7 and FIG. 8, the eardrum perforation patch of thesecond embodiment consists of parts of a disc-shaped closure piece 10, asupporting piece 12 and a column-shaped coupled 11. The patch is formedby monoblock molding of absorbable artificial material with biologicalaffinity, for example, collagen fiber. Therefore, the supporting piece12 and coupler 11 are one block. The maneuver to apply the patch is thesame as that of the first embodiment of the present invention. The meritis that the patch is made easily by machine production instead of byhand sewing.

Next, an eardrum undersurface scraper of the present invention will bedescribed. In FIG. 9 a perspective view of a first embodiment of theeardrum undersurface scraper of the present invention is shown. Theeardrum undersurface scraper consists of a head 13 with a blade edge, aneck 14 and a shaft 15. The head 13 with the blade edge is connected tothe shaft 15 by the neck 14. The neck 14 is curved and the blade edge isat an angle of more than 90 degrees and less than 360 degrees to theaxis of the shaft 15.

FIG. 10 is a partial enlarged view of the head 13 and the neck 14 of theeardrum undersurface scraper shown in FIG. 9. The width of the blade onhead 13 is 1 to 3 mm. and the head 13 is made of cutter stainless steel,and the other parts of the scraper other than the head 13 are made ofstructural stainless steel.

FIG. 11 is a schematic illustration of the first embodiment of theeardrum undersurface scraper of the present invention being applied tothe tympanic membrane shown in cross section. Through the tympanicperforation 5 the blade edge of the head 13 is inserted into the spacebehind the tympanic membrane 4. The curve of the neck 14 permits accessfor the blade edge of the head 13 to target points on the undersurface,by detouring the free margin of the tympanic perforation 5 and enteringinto the gap behind the tympanic membrane 4 apart from the perforationmargin.

A good view of the undersurface of the entire margin of the perforation5 and the blade edge of the head 13 are obtained looking through thesemitransparent tympanic membrane. After thrusting the blade edge of thehead 13 straight into the mucosal layer 7, by stroking it in thedirection of arrow B parallel to the tympanic membrane 4, the mucosallayer 7 behind the margin of the tympanic perforation 5 can be surelyand easily scraped off and raked out.

The mucosal layer 7, that is, the mucosal barrier on the undersurface ofthe tympanic membrane 4 is removed for a millimeter or two around theentire circumference of the tympanic perforation 5.

By this procedure, only through the original tympanic perforation 5vascular network on the lamina propria 8 is the undersurface of thetympanic membrane 4 exposed for a transplantation bed.

FIGS. 12 and 13 show a second embodiment of an eardrum undersurfacescraper of the present invention. An enlarged detail of the head andneck of the eardrum undersurface scraper is shown in FIG. 13. The neck17 of the eardrum undersurface scraper is curved and the head 16 of thescraper is under the shaft 18, and the blade edge of the head 16 is atan angle of about 270 degrees to the shaft 18.

FIG. 14 is a schematic illustration of the second embodiment of theeardrum undersurface scraper of the present invention being applied tothe tympanic membrane. The head 16 of the eardrum undersurface scraperreaches the undersurface of the nearer side of the tympanic membrane 4.By pushing the shaft 18 forward, the edge scrapes and rakes the mucosallayer 7 on the undersurface of the tympanic membrane 4.

FIG. 15 is a partial enlarged detail of the head and neck of a thirdembodiment of an eardrum undersurface scraper of the present invention.The undersurface scraper has a curved and twisted neck 20, and a head 19with a blade edge rotated and deviated laterally from the axis of theshaft 21.

FIG. 16 shows the third embodiment of the eardrum undersurface scraperof the present invention being applied to the tympanic membrane. Theblade edge of the head 19 scrapes and rakes out the mucosal layer on thelateral side of the perforation margin by stroking it in the directionof arrow D.

FIG. 17 shows the head and neck of a fourth embodiment of an eardrumundersurface scraper of the present invention. A head 22 with a bladeedge is connected to a neck 23 which is curved and twisted. The bladeedge of the head 22 is in the same plane with the axis of a shaft 24 andis at about 180 degrees to the axis.

FIG. 18 illustrates the head and neck of the fourth embodiment of aneardrum undersurface scraper of the present invention being applied tothe tympanic membrane. The blade edge of the head 22 is thrustedstraight into the mucosal layer 7 on the undersurface of the tympanicmembrane and is moved in the tangential direction of arrow E.

In actual surgery, an assortment of the scrapers including from thefirst to the fourth embodiment can be used in order to extend scrapingmucosal layer 7 on the undersurface around the tympanic perforation 5 inall directions.

FIG. 19 is an enlarged detail of the head and neck of a fifth embodimentof an eardrum undersurface scraper of the present invention. The head 25has blade edges radially arranged from the axis of the neck 26 on shaft27. With this scraper, the undersurface in all of the circumferentialmargin of the tympanic perforation can evenly be scraped.

FIG. 20 is an enlarged detail of the head and neck of a sixth embodimentof an eardrum undersurface scraper of the present invention. The head 28of the scraper has a circular blade edge on a circular belt. Head 28 isconnected to shaft 30 by the neck 29. This scraper scrapes all thecircumferential margin and yields a smooth surface of a grafting bed.

FIG. 21 is a partial enlarged view showing a detail of the head and neckof a seventh embodiment of an eardrum undersurface scraper of thepresent invention. This scraper has a neck 34 which consists of a pin 32and socket 33. The head 31 can be turned and its direction to the shaft35 is variable. This scraper scrapes the undersurface in all thecircumferential margin of the tympanic perforation.

The present invention is valuable as a material and a surgical tool fortympanic perforation repair, and its sure pinching mechanism, easysurgical maneuvering, and minimum harm provide a convenient operationand high success rate. It is useful in such fields as tympanicperforation repair for restoration of hearing function and curing eardischarge.

The invention being thus described, it will be obvious that the same maybe varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be obvious to one skilled in the art are intendedto be included within the scope of the following claims.

I claim:
 1. An eardrum perforation patch made of absorbable materialwith biological affinity for closing a tympanic perforation comprising:aclosure piece placeable inside the perforation for closing theperforation; at least one coupler connected to said closure piece forholding the closure piece against the perforation; and a supportingpiece placeable outside the perforation for supporting said closurepiece, the at least one coupler connecting the closure piece to thesupporting piece,the at least one coupler being thread which extendsbetween the closure piece and the supporting piece, the thread being theonly connection between the closure piece and the supporting piece. 2.The eardrum perforation patch as claimed in claim 1, wherein the closurepiece and the supporting piece are a same size and are generallyparallel.
 3. The eardrum perforation patch as claimed in claim 1,wherein at least one of the closure piece and the supporting piece aremade of collagen fiber membrane.
 4. The eardrum perforation patch asclaimed in claim 1, wherein the thread of at least one coupler is suturethread.
 5. The eardrum perforation patch as claimed in claim 1, whereinthe thread has two ends and is looped between the closure piece and thesupporting piece, the ends of the thread being knotted together adjacentthe supporting piece.
 6. The eardrum perforation patch as claimed inclaim 1, wherein the closure piece is flexible, the closure piece andthe supporting piece are movable toward one another except when theclosure piece is placed inside the perforation and the supporting pieceis placed outside the perforation with a tympanic membrane therebetween.7. The eardrum perforation patch as claimed in claim 1, wherein theclosure piece is a means for closing the perforation of a tympanicmembrane, the closure piece being made of absorbable material which hasgaps therein for receiving granulation tissue from the tympanic membranegaps such that the closure piece becomes tissue multiplication ground.8. A method for patching a perforation in a tympanic membrane comprisingthe steps of:providing a closure piece, a supporting piece and at leastone coupler, the at least one coupler connecting the supporting piece tothe closure piece; folding the closure piece; inserting the foldedclosure piece through the perforation in the tympanic membrane; andunfolding the closure piece after the step of inserting, the closurepiece being on an inside of the tympanic membrane and the supportingpiece being on an outside of the tympanic membrane with the couplerextending through the perforation.
 9. The method as recited in claim 8,further comprising the steps of:inserting a head with a blade edge of atleast one undersurface scraper through the perforation before the stepof inserting the folded closure piece; and scraping mucosa from theinside of the tympanic membrane with the blade edge of the at least onescraper to thereby prepare a grafting bed.
 10. The method as recited inclaim 8, wherein the step of unfolding comprises releasing a grip on theclosure piece such that the closure unfolds to return to an unfoldedshape.
 11. An eardrum perforation patch made of absorbable material withbiological affinity for closing a tympanic perforation comprising:aclosure piece placeable inside the perforation for closing theperforation; and means for holding the closure piece against theperforation, the means for holding consisting of a flexible threadconnected to said closure piece for holding the closure piece againstthe perforation, the thread being the only portion of the eardrumperforation patch adapted to extend into the perforation and into anexternal ear canal adjacent the tympanic perforation.
 12. The eardrumperforation patch as claimed in claim 11, wherein the closure piece ismade of collagen fiber membrane.
 13. A method for patching a perforationin a tympanic membrane comprising the steps of:providing a closure pieceand at least one coupler, the at least one coupler being connected tothe closure piece; folding the closure piece; inserting the foldedclosure piece through the perforation in the tympanic membrane; andunfolding the closure piece after the step of inserting, the closurepiece being on an inside of the tympanic membrane and the couplerextending through the perforation.
 14. The method as recited in claim13, further comprising the steps of:inserting a head with a blade edgeof at least one undersurface scraper through the perforation before thestep of inserting the folded closure piece; and scraping mucosa from theinside of the tympanic membrane with the blade edge of the at least onescraper to thereby prepare a grafting bed.
 15. The method as recited inclaim 13, wherein the step of unfolding comprises releasing a grip onthe closure piece such that the closure unfolds to return to an unfoldedshape.
 16. An eardrum perforation patch made of absorbable material withbiological affinity for closing a tympanic perforation comprising:aclosure piece placeable inside the perforation for closing theperforation; at least one coupler connected to said closure piece forholding the closure piece against the perforation; and a supportingpiece placeable outside the perforation for supporting said closurepiece, the at least one coupler connecting the closure piece to thesupporting piece, said closure piece, said supporting piece and saidcoupler being one block formed by monoblock molding, the at least onecoupler being a solid piece without any openings therein such thatcommunication through the coupler is prevented.
 17. The eardrumperforation patch as claimed in claim 16, wherein the closure piece andthe supporting piece are a same size and are generally parallel.